预约演示
更新于：2025-09-27
Dostarlimab-gxly
多塔利单抗
更新于：2025-09-27
概要
基本信息
药物类型 单克隆抗体 |
别名 Dostarlimab、Immunoglobulin G4, anti-programmed cell death protein 1 (PDCD1) (humanized clone ABT1 gamma4-chain), disulfide with humanized clone ABT1 kappa-chain, dimer、多斯塔利单抗 + [10] |
靶点 |
作用方式 抑制剂 |
作用机制 PD-1抑制剂(细胞程序性死亡-1抑制剂) |
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2021-04-21), |
最高研发阶段(中国)临床3期 |
特殊审评优先审评 (美国)、突破性疗法 (美国)、快速通道 (美国)、加速批准 (美国)、优先审评 (澳大利亚) |
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结构/序列
Sequence Code 315609369H
来源: *****
Sequence Code 315609370L
来源: *****
关联
104
项与 多塔利单抗 相关的临床试验NCT07108270
A Phase 2, Multicenter, Open-label, Single Arm Study of Dostarlimab Plus Carboplatin-paclitaxel Followed by Dostarlimab Monotherapy in Participants With dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer in China (China RUBY)
NCT07013851
Phase II Clinical Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer
NCT07115927
pReOperative Dostarlimab and Novel Therapies in EndOmetrial Cancer
100 项与 多塔利单抗 相关的临床结果
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100 项与 多塔利单抗 相关的转化医学
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100 项与 多塔利单抗 相关的专利（医药）
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186
项与 多塔利单抗 相关的文献（医药）2025-12-31Future Science OA
Immune checkpoint inhibitors or targeted therapy by mismatch repair status in endometrial cancer: a meta-analysis
Review
作者: Zeng, Ting ; Zhao, Jing ; Shu, Chuqiang ; Tang, Yi ; Chen, Yan ; Huang, Kui ; Zhang, Pu
OBJECTIVE:
This study evaluated the benefits of immune checkpoint inhibitors (ICIs) and/or targeted therapies in mismatch repair-deficient (dMMR) and mismatch repair-proficient (pMMR) patients with advanced or recurrent endometrial cancer (EC) via network meta-analysis.
METHODS:
English databases were searched from inception through January 2025. Randomized controlled trials (RCTs) assessing the efficacy and safety of related therapies for patients with EC stratified by MMR status were included. The main evaluation indicators included progression-free survival (PFS), overall survival (OS), the objective response rate (ORR), and severe adverse events (SAEs).
RESULTS:
Ten studies were included in the analysis. The results indicated that in the dMMR population, ICIs provide superior survival benefits. Among these, Dostarlimab combined with carboplatin and paclitaxel (CP) had the highest PFS and OS rates. For the pMMR population, Selinexor + CP offers significant benefits over CP alone, although OS outcome data are limited. In pMMR patients with prior chemotherapy, the lenvatinib + pembrolizumab strategy may provide additional PFS benefits relative to chemotherapy treatment.
CONCLUSIONS:
ICIs offered advantages for the dMMR population, whereas selinexor could provide survival benefits for the pMMR population. For pMMR patients who have received prior chemotherapy, the lenvatinib plus pembrolizumab strategy shows promise.
2025-08-14CLINICAL CANCER RESEARCH
Combined Targeting of PD-1 and TIM-3 in Patients with Locally Advanced or Metastatic Melanoma: AMBER Cohorts 1c, 1e, and 2A.
Article
作者: Jansen, Kathrin ; Davar, Diwakar ; Pérez, Casilda Llácer ; Di Pace, Brian ; Waszak, Angela ; Borgovan, Theo ; Ribas, Antoni ; Eroglu, Zeynep ; Wang, Tianli ; Ghosh, Srimoyee ; Dhar, Arindam ; Yanamandra, Niranjan
PURPOSE:
The phase I, open-label, multicenter AMBER study (NCT02817633) is evaluating cobolimab, an anti-T-cell immunoglobulin and mucin-domain containing protein-3 humanized mAb, as a monotherapy and combination therapy in patients with solid tumors. In this study, the safety and efficacy of cobolimab plus dostarlimab, a PD-1 inhibitor, in patients with locally advanced/metastatic melanoma who were either immunotherapy-naïve or had progressed on prior anti-PD-(L)1 therapy, are reported.
PATIENTS AND METHODS:
Adults with adequate organ function and either immunotherapy-naïve (parts 1c/1e) or anti-PD-(L)1 relapsed or refractory (part 2A) melanoma were enrolled and received cobolimab 100, 300, or 900 mg and dostarlimab 500 mg every 3 weeks. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, or death (whichever occurred sooner). Endpoints included safety, tolerability, overall response rate, and disease control rate.
RESULTS:
The current integrated analysis included 28 patients who received treatment in parts 1c/1e and 43 patients who received treatment in part 2A. Treatment-related serious adverse events were observed in 14.3% and 9.3% of patients in parts 1c/1e and 2A, respectively. The overall response rate (95% confidence interval) was 42.9% (24.5-62.8) and 4.7% (0.6-15.8) for patients in parts 1c/1e and 2A, respectively, and the disease control rate (95% confidence interval) was 53.6% (33.9-72.5; 1c/1e) and 20.9% (10.0-36.0; 2A).
CONCLUSIONS:
In this exploratory setting, cobolimab plus dostarlimab was well tolerated, with reported preliminary efficacy similar to other anti-T-cell immunoglobulin and mucin-domain containing protein-3 treatments in patients with locally advanced/metastatic melanoma. See related article by Davar et al., p. 3443.
2025-08-14CLINICAL CANCER RESEARCH
Combined Targeting of PD-1 and TIM-3 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer: AMBER Part 2B.
Article
作者: Davar, Diwakar ; Srivats, Shyam ; Milhem, Mohammed ; Gutierrez, Martin ; Yanamandra, Niranjan ; Zhang, Hailei ; Waszak, Angela ; Borgovan, Theo ; LoRusso, Patricia ; Eroglu, Zeynep ; Ghosh, Srimoyee ; Dhar, Arindam ; Wang, Tianli ; Di Pace, Brian ; Ribas, Antoni ; Becerra, Carlos
PURPOSE:
Treatment options for patients with non-small cell lung cancer (NSCLC) who have progressed on anti-PD-(L)1 treatment are lacking. In preclinical models, blockade of the inhibitory immune receptor T-cell immunoglobulin and mucin-domain containing protein 3 (TIM-3) is associated with an antitumor response. AMBER (NCT02817633) part 2B assessed the safety and efficacy of cobolimab, an anti-TIM-3 humanized monoclonal antibody, plus PD-1 inhibitor dostarlimab in patients with locally advanced or metastatic NSCLC who had progressed on anti-PD-(L)1 treatment.
PATIENTS AND METHODS:
Adult patients with anti-PD-(L)-1 treated locally advanced or metastatic NSCLC were included. Patients received cobolimab 100, 300, or 900 mg and dostarlimab 500 mg every 3 weeks. Treatment continued until disease progression, unacceptable toxicity, patient withdrawal, investigator's decision, or death. Endpoints included overall response rate, disease control rate, and safety. Post hoc biomarker assessments of pretreatment tumor biopsies were also assessed.
RESULTS:
In total, 85 patients were enrolled and 84 received treatment. Treatment-emergent and treatment-related adverse events occurred in 98.8% and 52.4% of patients, respectively; no treatment-related deaths occurred. Across all three cobolimab doses, overall response rate was 8.3% (95% confidence interval, 3.4-16.4) and disease control rate was 21.4% (95% confidence interval, 13.2-31.7); both were highest in the 300 mg cohort (n = 41; 9.8% and 22.0%). Pretreatment TIM-3 expression was significantly greater in patients with partial or stable responses versus progressive disease.
CONCLUSIONS:
Cobolimab plus dostarlimab showed preliminary efficacy and tolerability in a subset of patients with locally advanced/metastatic NSCLC. See related article by Davar et al., p. 3433.
100 项与 多塔利单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 晚期子宫内膜癌 | 欧盟 | 2024-01-12 | |
| 晚期子宫内膜癌 | 冰岛 | 2024-01-12 | |
| 晚期子宫内膜癌 | 列支敦士登 | 2024-01-12 | |
| 晚期子宫内膜癌 | 挪威 | 2024-01-12 | |
| 复发性子宫内膜癌 | 欧盟 | 2024-01-12 | |
| 复发性子宫内膜癌 | 冰岛 | 2024-01-12 | |
| 复发性子宫内膜癌 | 列支敦士登 | 2024-01-12 | |
| 复发性子宫内膜癌 | 挪威 | 2024-01-12 | |
| MMRD实体瘤 | 美国 | 2021-08-17 | |
| MSI-H 子宫内膜癌 | 欧盟 | 2021-04-21 | |
| MSI-H 子宫内膜癌 | 冰岛 | 2021-04-21 | |
| MSI-H 子宫内膜癌 | 列支敦士登 | 2021-04-21 | |
| MSI-H 子宫内膜癌 | 挪威 | 2021-04-21 | |
| 错配修复缺陷子宫内膜癌 | 欧盟 | 2021-04-21 | |
| 错配修复缺陷子宫内膜癌 | 冰岛 | 2021-04-21 | |
| 错配修复缺陷子宫内膜癌 | 列支敦士登 | 2021-04-21 | |
| 错配修复缺陷子宫内膜癌 | 挪威 | 2021-04-21 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| PD-L1阳性非小细胞肺癌 | 临床3期 | 美国 | 2024-06-10 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 中国 | 2024-06-10 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 日本 | 2024-06-10 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 阿根廷 | 2024-06-10 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 比利时 | 2024-06-10 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 巴西 | 2024-06-10 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 保加利亚 | 2024-06-10 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 加拿大 | 2024-06-10 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 芬兰 | 2024-06-10 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 法国 | 2024-06-10 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 22 | 範鹹鹽餘願壓廠獵蓋觸 = 積網艱糧憲遞構築齋淵 獵鬱鬱膚鹽鏇糧簾願鹹 (繭窪鏇製夢淵鹽網膚簾, 糧淵構夢膚鹽鹹築鹽衊 ~ 鑰膚糧醖壓願鏇憲壓衊) 更多 | - | 2025-08-07 | |||
临床2期 | 77 | (Cohort A (Dostarlimab + Bevacizumab + Niraparib)) | 遞鏇鹽遞蓋獵窪選範憲 = 製鬱顧築壓蓋積餘艱獵 鑰蓋遞顧選鑰鹹築願餘 (齋積襯構餘鑰醖簾觸築, 膚觸廠夢壓襯衊鑰壓鬱 ~ 淵夢網糧壓鹹鏇蓋壓襯) 更多 | - | 2025-07-15 | ||
taxane+Niraparib (Cohort C (Niraparib OR Platinum-taxane)) | 遞鏇鹽遞蓋獵窪選範憲 = 蓋衊遞遞範鬱鏇鏇獵願 鑰蓋遞顧選鑰鹹築願餘 (齋積襯構餘鑰醖簾觸築, 壓獵窪淵觸憲製齋糧齋 ~ 膚鬱襯鏇艱鑰膚夢齋構) 更多 | ||||||
临床3期 | 复发性子宫内膜癌 dMMR/MSI-H | MMRp/MSS | 494 | Dostarlimab plus Carboplatin-Paclitaxel (DOST+CP) | 衊廠餘積餘鹽淵蓋鬱製(觸築膚壓簾襯壓鏇鹹遞) = 壓築鑰衊範觸餘襯鏇網 遞簾襯網鹽襯簾膚獵製 (繭觸網廠願鑰範遞淵鹹 ) 更多 | 积极 | 2025-05-30 | |
Placebo plus Carboplatin-Paclitaxel (PBO+CP) | 衊廠餘積餘鹽淵蓋鬱製(觸築膚壓簾襯壓鏇鹹遞) = 窪艱壓廠膚鏇鏇鹽餘廠 遞簾襯網鹽襯簾膚獵製 (繭觸網廠願鑰範遞淵鹹 ) 更多 | ||||||
临床2期 | 117 | 簾憲襯築簾遞衊範淵齋(顧獵獵築鏇齋選獵糧願) = 遞齋艱壓鏇選繭衊醖鑰 構範構窪顧鏇遞築觸廠 (窪遞鬱繭壓選鏇鏇襯願 ) 更多 | 积极 | 2025-04-27 | |||
(dMMR, locally advanced rectal cancer) | 獵範壓鬱襯鬱齋鑰衊鹽(糧糧壓糧醖鬱觸夢襯製) = 鑰蓋醖憲範夢選壓廠夢 構願構鹽築醖淵構簾鹽 (蓋膚遞餘簾簾構觸憲選 ) 更多 | ||||||
临床1期 | 67 | (SerialCTRS) | 醖範蓋顧鬱餘鹹齋選壓(網構艱艱積艱鬱襯糧淵): HR = 2.68 (95% CI, 1.09 ~ 6.59), P-Value = 0.03 | 积极 | 2025-04-27 | ||
(RECIST 1.1) | |||||||
临床1/2期 | 4 | 遞鹽遞獵憲構淵襯顧製 = 憲鬱齋淵鑰齋願醖願鑰 簾艱憲觸顧願製膚網選 (觸淵醖鏇衊鏇繭蓋壓蓋, 鏇選顧遞艱鹹製艱襯襯 ~ 簾積選壓鹽鹽窪鹹窪鹹) 更多 | - | 2025-03-03 | |||
临床1期 | - | Encelimab + Dostarlimab | 衊鑰淵蓋醖夢願鑰艱鹹(餘襯獵積簾艱廠願構遞) = 憲醖艱夢醖簾廠製窪範 憲鹽選醖淵鹹壓鬱鏇蓋 (窪衊積廠鏇遞願範齋鹹 ) | 不佳 | 2025-02-27 | ||
衊鑰淵蓋醖夢願鑰艱鹹(餘襯獵積簾艱廠願構遞) = 願壓淵遞夢壓壓獵夢淵 憲鹽選醖淵鹹壓鬱鏇蓋 (窪衊積廠鏇遞願範齋鹹 ) | |||||||
临床3期 | 卵巢癌 一线 | - | SOC + Placebo | 廠網鬱願糧憲餘夢鏇鏇(鹹糧簾觸遞廠願淵艱構) = The trial met its primary endpoint of PFS demonstrating a statistically significant difference with the addition of dostarlimab to both standard of care carboplatin-paclitaxel chemotherapy and niraparib maintenance, with or without bevacizumab. 艱遞積蓋獵鑰獵壓觸鏇 (壓艱製鹹鏇範製觸齋簾 ) 达到 更多 | 积极 | 2024-12-20 | |
SOC + niraparib | |||||||
临床2期 | 42 | 鑰鏇網選窪餘廠網衊鏇(鬱遞醖鑰鬱醖構膚醖選) = 鑰壓簾齋憲鏇艱積壓鑰 鹹齋選糧鬱憲獵構願衊 (壓糧糧築遞衊膚糧齋繭 ) | 积极 | 2024-12-16 | |||
N/A | 复发性子宫内膜癌 dMMR | MSI-H | 29 | 夢簾衊願蓋壓築憲遞鏇(築醖網餘鹽鏇遞衊積鹽) = Serious AEs occurred in 4 (13.8%) pts; none were directly related to treatment 鹹網醖餘鏇簾鬱壓齋鑰 (廠夢願獵遞鹽構願膚築 ) 更多 | 积极 | 2024-12-07 |
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